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NCT04428203 · ClinicalTrials.gov registry record · Phase 1
Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer
A Phase 1 study, sponsored by Zin W Myint.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT04428203: Completed Phase 1 study, sponsored by Zin W Myint.
NCT04428203 is a Phase 1 study that has completed, run by Zin W Myint. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04428203, a Phase 1 study, has completed, sponsored by Zin W Myint.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this phase I/Ib study is to determine the safety profile of Epidiolex (CBD oil) in biochemically recurrent prostate cancer patients. The study consists of a dose escalation part and dose expansion part. The dose expansion part of the study will use the maximum tolerated dose (MTD) determined in the dose escalation part to assess the activity, safety and tolerability of the investigational product in patients with biochemically recurrent prostate cancer after localized therapy with either surgery or radiation.
Primary Outcome
DLT was defined as grade ≥3 nausea, vomiting, diarrhea that persists \>72 h despite optimal anti-emetics and anti-diarrhea treatment, grade ≥3 hematological adverse events (AEs), or grade ≥2 suicidal ideation.Treatment-related adverse events are those that comprise a dose-limiting toxicity within 30 days after initiation of Epidiolex (i.e., acute DLT). Additionally, Treatment-related adverse events will continue to be monitored for a total of 90 days.
Interventions
- DRUG Epidiolex Oral Liquid Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2021-08-20 |
| Phase | Phase 1 |
What the finished NCT04428203 record still lists
NCT04428203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Epidiolex Oral Liquid Product is the first listed.
NCT04428203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04428203 about?
NCT04428203 is a clinical study titled "Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer". The purpose of this phase I/Ib study is to determine the safety profile of Epidiolex (CBD oil) in biochemically recurrent prostate cancer patients. The study consists of a dose escalation part and dose expansion part. The dose expansion part of the study will use the maximum tolerated dose (MTD) det...
What is the current status of trial NCT04428203?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2020-08-03. Estimated completion is 2021-08-20.
What interventions are being tested in trial NCT04428203?
The interventions under investigation include: Epidiolex Oral Liquid Product (DRUG).
Who is sponsoring clinical trial NCT04428203?
This trial is sponsored by Zin W Myint, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04428203's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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